Articles from Newron Pharmaceuticals S.p.A.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2024, and provided an outlook for 2025.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for diseases of the central and peripheral nervous system, today announced that its Board of Directors has identified Chris Martin, DPhil, as a potential Independent Non-Executive Director and Chairman of the Board and will propose him for election at Newron’s upcoming Annual General Meeting (AGM), to be held on April 23, 2025, in Bresso (Mi), Italy. Martin is an accomplished public and private company director with deep expertise in commercial drug development and a proven track record in founding and leading successful biopharma companies. He is expected to succeed Ulrich Köstlin, who has served as Chairman of the Board since 2013. Köstlin will end his board service following the completion of this year’s AGM.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for diseases of the central and peripheral nervous system, today announced that Stefan Weber, CEO, will participate in a fireside chat at the 37th Annual ROTH Conference on Monday, March 17 at 11:30 a.m. PDT.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for diseases of the central and peripheral nervous system, and Myung In Pharm Co. Ltd. (“Myung In Pharm”), South Korea’s leading CNS specialist pharmaceutical company, today announced that they have entered into a license agreement to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, an add-on therapy for treatment-resistant schizophrenia (TRS) and poorly responding patients with schizophrenia, in South Korea.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, and EA Pharma Co., Ltd. (Head Office, Chuo-ku, Tokyo, Japan; President, Hidenori Yabune; “EA Pharma”), a subsidiary of Eisai Co., Ltd., today announced that they have entered into a license agreement to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, in Japan and other designated Asian territories1.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half year ended June 30, 2024, and provided an update on its business activities.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), welcomed investors, analysts and media today to its well-attended investor day in New York City. The event focused on the Company’s clinical, scientific and commercial plans for evenamide, its investigational drug candidate in Phase III clinical development for the potential treatment of patients with chronic and TRS.

Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today announced that it will host its 2024 Investor Day on Tuesday, June 25, 2024, at Convene, 530 Fifth Avenue (between 44th and 45th Streets) in New York City, from 9:00-11:00 AM EDT.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today announced that it will host its 2024 Investor Day on Tuesday, June 25, 2024, in New York City.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presents additional results from the international, randomized, double-blind, placebo-controlled study 008A that evaluated the efficacy and safety of evenamide (30 mg bid) as add-on treatment in 291 patients not benefitting from their second-generation antipsychotic medication, including clozapine. Initial top line data announced on 30th April 2024 demonstrated that the study met its primary endpoint, an improvement of the Positive and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary endpoint, an improvement of the Clinical Global Impression of Severity (CGI-S), in the a-priori defined regulatory analysis.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today announced positive top-line results from its potentially pivotal study 008A, evaluating the safety, tolerability and efficacy of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic including clozapine, but demonstrating an inadequate response to that treatment. The study met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary endpoint of improvement of the Clinical Global Impression of Severity (CGI-S).

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presented four posters and two oral presentations at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) from 3-7 April in Florence, Italy. The data presented were detailing previously reported scientific results of study 014/015, the future clinical development outlook for evenamide and information on study 008A.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today reports agreement with the European Investment Bank (EIB) on an amendment to certain terms of its 2018 financing agreement.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today reported positive final, one-year results from its open label study 014/015, evaluating its investigational drug evenamide as an add-on to antipsychotics for the management of treatment-resistant schizophrenia (TRS). The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the completion of patient enrollment in study 008A, its potentially pivotal study with evenamide in patients suffering from schizophrenia.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today at 12:35 pm CEST presented new data from study 014/015 evaluating its investigational drug evenamide for the management of treatment resistant schizophrenia (TRS). The data, which demonstrated that evenamide treatment was associated with an increasing, sustained, and clinically significant improvement of symptoms were presented at the 36th European Clinical Neuropsychopharmacology Congress (ECNP) in Barcelona, Spain.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announced that it will present three posters at the upcoming 36th European College of Neuropsychopharmacology (ECNP) Congress taking place October 7-10, 2023, at the Centre Convencions Internacional de Barcelona (CCIB) in Barcelona, Spain.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous (CNS) system, today announced that Margarita Chavez has been appointed as an advisor to the Board of Directors of Newron, bringing significant pharmaceutical business development (BD) and dealmaking expertise. It is intended that Margarita Chavez will be nominated for election to the Board of Directors at Newron’s next Ordinary Annual General Meeting (AGM) of Shareholders in spring 2024.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half year ended June 30, 2023, and provided an update on its R&D and business activities.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presented substantial additional data from its study 014/015 at the 34th CINP World Congress of Neuropsychopharmacology from 7-10 May 2023 in Montreal, Québec, Canada, and the 2023 Congress of the Schizophrenia International Research Society (SIRS) from 11-15 May 2023 in Toronto, Ontario, Canada.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), announced that it will present six posters in various presentation formats at the upcoming 34th CINP World Congress of Neuropsychopharmacology, taking place 7-10 May 2023 at the Fairmont The Queen Elizabeth hotel in Montreal, Québec, Canada, and the 2023 Congress of the Schizophrenia International Research Society (SIRS) taking place 11-15 May 2023 at The Westin Harbour Castle in Toronto, Ontario, Canada.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that the Board of Directors has approved the following changes and promotions within the Senior Management Team:

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presented two e-posters at today’s “Schizophrenia and other psychotic disorders” session at the 31st European Congress of Psychiatry, taking place at the Palais des Congrès in Paris, France.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), announces exciting topline results from Study 014, a phase II, international, randomized, open label, rater-blinded trial evaluating evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS) not responding to their current antipsychotic medication. While the primary objective of the study was safety and tolerability of the drug, efficacy over baseline was also assessed. Interim results from the first 100 patients at six weeks were previously reported in June 2022.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), announced that it will present two e-posters at the 31st European Congress of Psychiatry, taking place on 25-28 March 2023, at the Palais des Congrès of Paris - Place de la Porte Mailot in Paris, France.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), announces very exciting new results from the first 100 randomized patients who have completed one year (52 weeks) of treatment in its international, randomized, open label, rater-blinded study of evenamide (study 014/015) as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS) not responding to their current antipsychotic medication. Results from these same 100 patients at six weeks and six months in study 014/015 have been reported previously.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), announces very compelling new results from the first 100 enrolled patients to have reached the six-month (30 weeks) timepoint in its international, randomized, open label, rater-blinded study of evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS), who were not responding to their current antipsychotic medication (study 014/015). 85 of the 100 patients completed the 30-week treatment period with evenamide. The results follow on from the Company’s announcement on June 7, 2022, summarizing the data from an interim analysis of the first 100 patients to have finished six weeks of treatment in this study.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half year ended June 30, 2022 and provided an update on its R&D and business activities.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today announced encouraging interim results from the first 100 patients in its world-first, international, six-week, open-label, randomized, rater-blinded, multi-centre study of evenamide as an add-on to an antipsychotic in patients with moderate to severe treatment-resistant schizophrenia (TRS) who were not responding to current antipsychotic medication.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the year ended December 31, 2021, and provided an outlook for 2022.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announces that it has received Tranche 5 under its financing agreement with the European Investment Bank (EIB) that was signed in October 2018 and comprises up to EUR 40 million, subject to achieving a set of agreed performance criteria. The EIB loan is backed by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment plan for Europe. Tranche 5 consists of EUR 7.5 million and will primarily be used to support the Company’s development programs in diseases of the central nervous system. The first four tranches of the loan, totaling EUR 32.5 million, were received by Newron in 2019, 2020 and in September 2021.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its operational highlights and financial results for the half-year ended June 30, 2021.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that with reference to its media release of May 4, 2021, it received further Paragraph IV Notice Letters regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the U.S. before expiration of certain US patents. Such further Paragraph IV Notice Letters are not unusual and additional similar notices from other generic manufacturers may follow.

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that it received a Paragraph IV Notice Letter regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the U.S. before expiration of certain US patents.